CN114042206A

CN114042206A - Fixed connector system for venting from a fluid reservoir

Info

Publication number: CN114042206A
Application number: CN202111339912.8A
Authority: CN
Inventors: 萨尔纳斯·沙塔尔杰; 根·H·丹格; 普纳姆·S·古拉蒂
Original assignee: Medtronic Minimed Inc
Current assignee: Medtronic Minimed Inc
Priority date: 2016-04-27
Filing date: 2017-03-30
Publication date: 2022-02-15
Also published as: DK3448458T3; WO2017189161A1; CN109069735B; EP3448458A1; US20170312454A1; US10589038B2; CA3017979A1; EP3448458B1; CN109069735A; US20200164159A1; US11547811B2

Abstract

The present invention provides a fixed connector system for venting gas from a fluid reservoir of a fluid infusion device. The fixed connector system includes a connector system having a first body portion coupled to a second body portion. The first body portion defines an aperture in communication with the chamber and the counterbore of the second body portion to define a fluid flow path from the fluid reservoir. The chamber of the second body portion is in fluid communication with an exhaust subsystem defined by the second body portion. The exhaust subsystem terminates in an outlet and directs gas in the fluid flow path through the second body portion to the outlet.

Description

Fixed connector system for venting from a fluid reservoir

The application has the application number of 201780023134.7, the application date of 2017, 3 and 30 months and the invention name of "For Fixed connector system for venting from a fluid reservoir"the divisional application of the Chinese invention patent application.

Cross Reference to Related Applications

This PCT application claims the benefit and priority of U.S. patent application serial No. 15/140,229 filed on 27/4/2016; and the contents of the above-mentioned application are incorporated herein by reference.

Technical Field

Embodiments of the subject matter described herein relate generally to fluid infusion devices for delivering a drug fluid to the body of a user. More particularly, embodiments of the subject matter relate to a fixed connector system for venting gas from a fluid reservoir of a fluid infusion device.

Background

According to modern medical technology, certain diseases or conditions may be treated by delivering drugs or other substances to the body of the user in a continuous manner over a total period of time or at specific times or at specific time intervals. For example, diabetes is often treated by delivering a defined amount of insulin to the user at the appropriate time. Some common modes of providing insulin therapy to users include delivering insulin by manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to a user.

A fluid infusion device suitable for use as an insulin pump may be implemented as an external device or an implantable device that is surgically implanted within the body of a user. External fluid infusion devices include devices designed for use in a generally fixed location (e.g., at a hospital or clinic) as well as devices configured for ambulatory or portable use (to be carried by a user). An external fluid infusion device may establish a fluid flow path from a fluid reservoir to a patient via, for example, suitable hollow tubing. In many cases, the fluid reservoir needs to be filled by the patient before being used in an external fluid infusion device. During filling of the fluid reservoir, gas, such as air, may be inadvertently trapped in the fluid reservoir.

Accordingly, it is desirable to provide a fixed connector system for venting gas, such as air, from a fluid reservoir used with a fluid infusion device. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.

Disclosure of Invention

The object of the invention is achieved by the subject matter of the independent claims; further embodiments are incorporated in the dependent claims.

According to various embodiments, a fixed connector system for venting gas from a fluid reservoir of a fluid infusion device is provided. The fixed connector system includes a connector system having a first body portion coupled to a second body portion. The first body portion defines an aperture in communication with the chamber and the counterbore of the second body portion to define a fluid flow path from the fluid reservoir. The chamber of the second body portion is in fluid communication with an exhaust subsystem defined by the second body portion. The exhaust subsystem terminates in an outlet and directs gas in the fluid flow path through the second body portion to the outlet.

Fluid infusion devices are also provided according to various embodiments. The fluid infusion device includes a housing that receives a fluid reservoir, and a stationary connector system for venting gas from the fluid reservoir. The fixed connector system includes a connector system having a first body portion coupled to a second body portion. The first body portion defines an aperture. The second body portion includes a counterbore that receives a portion of the fluid reservoir. The aperture of the first body portion and the counter bore of the second body portion cooperate to define a fluid flow path from the fluid reservoir. The second body portion includes an exhaust subsystem in communication with the fluid flow path, the exhaust subsystem terminating at an outlet, and the exhaust subsystem directing gas in the fluid flow path to the outlet.

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

Drawings

A more complete understanding of the present subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures.

Fig. 1 is a simplified block diagram representation of an embodiment of a fluid delivery system according to various embodiments;

FIG. 2 is a plan view of an exemplary embodiment of a fluid delivery system including a fluid infusion device having an exemplary fixed connector system for venting gas from a fluid reservoir in accordance with various teachings of the present disclosure;

FIG. 3 is a cross-sectional view of the fluid infusion device of FIG. 2, taken along line 3-3 of FIG. 2;

FIG. 3A is a cross-sectional view of the fluid infusion device of FIG. 2, taken along line 3A-3A of FIG. 2;

FIG. 4 is a perspective view of a connector system of the fixed connector system of FIG. 2 according to various teachings of the present disclosure;

FIG. 5 is a detailed cross-sectional view of the connector system of FIG. 4 taken from detail 5 of the cross-sectional view of FIG. 2;

FIG. 6 is a cross-sectional view of the connector system of FIG. 4 taken along line 6-6 of FIG. 4;

FIG. 7 is a plan view of an exemplary embodiment of a fluid delivery system including a fluid infusion device having an exemplary fixed connector system for venting gas from a fluid reservoir in accordance with various teachings of the present disclosure;

FIG. 8 is a cross-sectional view of the fluid infusion device of FIG. 7, taken along line 8-8 of FIG. 7;

FIG. 9 is a perspective view of a connector system of the fixed connector system of FIG. 7 according to various teachings of the present disclosure;

fig. 10 is a perspective view of the fluid infusion device of fig. 7 with a portion of the housing of the fluid infusion device shown in phantom; and is

Fig. 10A is an exploded view of one or more rings and a sealing member associated with the housing of the fluid infusion device of fig. 7.

Detailed Description

The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration. Any specific implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

Certain terminology may also be used in the following description for reference only and is therefore not intended to be limiting. For example, terms such as "top," "bottom," "upper," "lower," "above," and "below" may be used to refer to directions in the drawings to which reference is made. Terms such as "front," "back," "rear," "side," "outer," and "inner" may be used to describe the orientation and/or position of portions of the component within a consistent but arbitrary frame of reference, which may be clearly understood by reference to the text and associated drawings describing the component in question. Such terms may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms "first," "second," and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.

As used herein, the term "module" refers to any hardware, software, firmware, electronic control component, processing logic, and/or processor device, alone or in any combination, including but not limited to: an Application Specific Integrated Circuit (ASIC), an electronic circuit, a processor (shared, dedicated, or group) and memory that execute one or more software or firmware programs, a combinational logic circuit, and/or other suitable components that provide the described functionality.

Embodiments of the disclosure may be described herein in terms of functional and/or logical block components and various processing steps. It should be appreciated that such block components may be realized by any number of hardware, software, and/or firmware components configured to perform the specified functions. For example, embodiments of the present disclosure may employ various integrated circuit components, e.g., memory elements, digital signal processing elements, logic elements, look-up tables, or the like, which may carry out a variety of functions under the control of one or more microprocessors or other control devices.

For the sake of brevity, conventional techniques related to signal processing, data transmission, signaling, control, and other functional aspects of the systems (and the individual operating components of the systems) may not be described in detail herein. Furthermore, the connecting lines shown in the various figures contained herein are intended to represent example functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in an embodiment of the disclosure.

The following description relates to fluid infusion devices of the type used to treat a medical condition of a user. The infusion device may be used to infuse a fluid into the body of a user. The non-limiting examples described below relate to medical devices (more specifically, insulin pumps) for treating diabetes, but embodiments of the presently disclosed subject matter are not so limited. Thus, in certain embodiments, the infused pharmaceutical fluid is insulin. However, in alternative embodiments, many other fluids may be administered by infusion, such as, but not limited to, disease therapeutics, drugs to treat pulmonary hypertension, iron-chelating drugs, pain medications, anti-cancer therapeutics, drugs, vitamins, hormones, and the like. For the sake of brevity, conventional features and characteristics associated with infusion system operations, insulin pump and/or infusion set operations, fluid reservoirs, and fluid injectors may not be described in detail herein. Examples of infusion pumps and/or associated pump drive systems for administering insulin and other medications may be of the type described in, but are not limited to, the following U.S. patents: U.S. patent publications 2009/0299290 and 2008/0269687; U.S. patents 4,562,751, 4,678,408, 4,685,903, 5,080,653, 5,505,709, 5,097,122, 6,485,465, 6,554,798, 6,558,351, 6,659,980, 6,752,787, 6,817,990, 6,932,584, 7,621,893, 7,828,764, and 7,905,868, each of which is incorporated herein by reference.

Fig. 1 is a simplified block diagram representation of an embodiment of a fluid delivery system 100 that may be used to administer a pharmaceutical fluid, such as insulin, to a patient. The fluid delivery system 100 includes a fluid infusion device 102 (e.g., an infusion pump) and a fluid conduit assembly 104 coupled, integrated, or otherwise associated with the fluid infusion device 102. The fluid infusion device 102 includes a fluid reservoir 106 or equivalent supply of drug fluid to be administered. The fluid infusion device 102 operates in a controlled manner to deliver medication fluid to a user via the fluid conduit assembly 104. Although not shown in fig. 1, the fluid infusion device 102 also includes a fixed connector system for venting gas from the fluid reservoir 106.

The fluid infusion device 102 may be provided in any desired configuration or platform. According to one non-limiting embodiment, the fluid infusion device is implemented as a portable unit that can be carried or worn by the patient. In this regard, fig. 2 is a plan view of an exemplary embodiment of a fluid delivery system 200 that includes a portable fluid infusion device 202 and a fluid conduit assembly in the form of an infusion set component 204. The infusion set component 204 is coupled to the fluid infusion device 202. The fluid infusion device 202 houses a fluid reservoir (shown in fig. 3) for delivering the drug fluid to the user.

The illustrated embodiments of the infusion set component 204 include, but are not limited to: a tube 210; an infusion unit 212 coupled to the distal end of the tube 210; and a fixed connector system 214 coupled to the proximal end of the tube 210. The infusion set component 204 defines a fluid flow path that fluidly couples the fluid reservoir to the infusion unit 212. The fluid infusion device 202 is designed to be carried or worn by a patient and the infusion set component 204 terminates in an infusion unit 212 such that the fluid infusion device 202 can deliver fluid to the body of the patient via tubing 210. The fluid infusion device 202 may utilize a number of conventional features, components, elements, and characteristics of existing fluid infusion devices. For example, the fluid infusion device 202 may incorporate some of the features, components, elements, and/or characteristics described in U.S. Pat. nos. 6,485,465 and 7,621,893, the relevant contents of which are incorporated herein by reference.

In this example, the fluid infusion device 202 includes a user interface 216 and a display 218 coupled to a housing 220. The user interface 216 includes one or more input devices 222 that can be activated by a user. The user interface 216 may be used to administer insulin doses, change therapy settings, change user preferences, select display features, and the like. Although not required, an exemplary embodiment of the fluid infusion device 202 includes a display 218. The display 218 may be used to present various types of information or data to the user, such as, but not limited to: the current glucose level of the patient; time; a graph or chart of glucose levels versus time for the patient; device status indicators, and the like. In some embodiments, the display 218 is implemented as a touch screen display element, and thus the display 218 also serves as a user interface component.

Referring to fig. 3, the housing 220 of the fluid infusion device 202 houses a power source 224, a controller or control module 226, a drive system 228, and a fluid reservoir system 230. In certain embodiments, the housing 220 further includes a lock 232 that securely couples the fluid reservoir system 230 to the housing 220, as will be discussed in greater detail herein. Generally, the power source 224, control module 226, and drive system 228 are housed in a pump chamber 220a defined by the housing 220, and the fluid reservoir system 230 is housed in a reservoir chamber 220b defined by the housing 220. Referring to fig. 3A, the housing 220 further includes a vent chamber 220c defined adjacent to the reservoir chamber 220 b. As will be discussed, the exhaust plenum 220c may be in fluid communication with the fixed connector system 214 to receive fluid, such as air, exhausted from the fixed connector system 214. Vent chamber 220c is generally fluidly isolated from or not in fluid communication with pump chamber 220 a. The housing 220 may have any desired shape to accommodate the various components of the fluid infusion device 202, and thus, it should be understood that the shape and configuration of the housing 220 shown herein is merely exemplary.

Referring again to fig. 3, the power source 224 is any suitable device for providing power to the fluid infusion device 202, including but not limited to a battery. In one example, the power source 224 may be removed relative to the housing 220; however, the power source 224 may also be secured within the housing 220. The control module 226 communicates with the user interface 216, the display 218, the power source 224, and the drive system 228. The control module 226 controls operation of the fluid infusion device 202 based on patient-specific operating parameters. For example, the control module 226 controls the provision of power from the power source 224 to the drive system 228 to activate the drive system 124 to dispense fluid from the fluid reservoir system 230. Further details regarding the control of the fluid infusion device 202 may be found in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant contents of which were previously incorporated herein by reference.

The drive system 228 cooperates with the fluid reservoir system 230 to dispense fluid from the fluid reservoir system 230. In one example, the drive system 228 includes a motor 234, a gear box 236, a drive screw 238, and a slide 240. The motor 234 receives power from the power source 224 under the control of the control module 226. In one example, the motor 234 is an electric motor. The motor 234 includes an output shaft 234 a. The output shaft 234a is coupled to a gearbox 236. In one embodiment, the gearbox 236 is a reduction gearbox. The gear box 236 includes an output shaft 236a coupled to a drive screw 238.

Drive screw 238 includes a generally cylindrical distal portion 242 and a generally cylindrical proximal portion 244. The diameter of the distal portion 242 may be greater than the diameter of the proximal portion 244. The distal portion 242 includes a plurality of threads 242 a. A plurality of threads 242a are generally formed around the outer circumference of the distal portion 242. The proximal portion 244 is generally unthreaded and may be sized to be received within a portion of the slider 240. For example, the proximal portion 244 may be used to align the drive screw 238 within the sled 240 during assembly.

With continued reference to fig. 3, the slider 240 is substantially cylindrical and includes a distal slider end 246, a proximal slider end 248, and a plurality of threads 250. When the slide 240 is in the first fully retracted position, the distal slide end 246 is adjacent the motor 234, and when the slide 240 is in the first fully retracted position, the proximal slide end 248 is adjacent the drive screw 238. Proximal slider end 248 includes a protrusion 252 and a shoulder 254 that cooperate with fluid reservoir system 230 to dispense fluid from fluid reservoir system 230. A shoulder 254 is defined adjacent to the protrusion 252 and contacts a portion of the fluid reservoir system 230 to dispense fluid from the fluid reservoir system 230.

A plurality of threads 250 of the slider 240 are formed along the interior surface 240a of the slider 240 between the distal slider end 246 and the proximal slider end 248. The plurality of threads 250 are formed to threadingly engage the threads 242a of the drive screw 238. Thus, rotation of drive screw 238 results in linear translation of slide 240.

In this regard, the slide 240 is generally sized such that in the first, retracted position, the motor 234, the gear box 236, and the drive screw 238 are substantially surrounded by the slide 240. The slide 240 is movable to a second, fully extended position by operation of the motor 234. The slide 240 is also movable to a plurality of positions between a first retracted position and a second fully extended position via operation of the motor 234. Generally, operation of the motor 234 rotates an output shaft 234a coupled to a gearbox 236. The gear box 236 reduces the speed and increases the torque output by the motor 234, and the output shaft 236a of the gear box 236 rotates the drive screw 238 that moves along the threads 250 formed in the slide 240. Movement or rotation of the drive screw 238 relative to the slide 240 results in movement or linear translation of the slide 240 within the housing 220. The forward advancement of the slide 240 (i.e., the movement of the slide 240 toward the fluid reservoir system 230) causes the fluid reservoir system 230 to dispense fluid.

With continued reference to fig. 3, the fluid reservoir system 230 includes a fluid reservoir 256 and a sealing member 258. The fluid reservoir 256 and the sealing member 258 are each received within an opening defined by the housing 220. A sealing member 258 is coupled between the fluid reservoir 256 and the stationary connector system 214 to prevent fluid from entering the reservoir chamber 220b of the housing 220. In one example, the sealing member 258 comprises an O-ring; however, as will be appreciated by those skilled in the art, any suitable means may be used to prevent fluid ingress.

Referring to fig. 3, the fluid reservoir 256 includes a body or barrel 260 and a stop 262. The cylinder 260 has a first or distal cylinder end 264 and a second or proximal cylinder end 266. The fluid 265 is retained within the cylinder 260 between the distal cylinder end 264 and the proximal cylinder end 266. When the fluid reservoir 256 is assembled in the housing 220, the distal cylinder end 264 is positioned adjacent to the slide 240. In general, distal barrel end 264 may have a substantially open perimeter or may be substantially circumferentially open such that slider 240 is receivable within barrel 260 through distal barrel end 264.

The proximal cylinder end 266 may have any desired size and shape configured to mate with at least a portion of the fixed connector system 214, as will be discussed in further detail herein. In one example, the proximal cylinder end 266 defines a passage 266a through which the fluid 265 flows out of the fluid reservoir 256. The passage 266a is closed by a partition 268. The spacer 268 is received within a portion of the proximal cylinder end 266 and is coupled to the proximal cylinder end 266 by any suitable technique, such as ultrasonic welding, press fitting, etc. The partition 268 acts as a barrier to prevent fluid from entering the fluid reservoir system 230 and to prevent fluid from exiting the fluid reservoir 256. The septum 268 may be pierced by the fixed connector system 214 to define a fluid flow path out of the fluid reservoir 256. In one example, the stationary connector system 214 includes a connector system 270, a hollow instrument or needle 272, and a tube 210. As will be discussed, connector system 270 couples needle 272 and tube 210 to fluid reservoir 256 and includes an exhaust subsystem 318 to exhaust trapped gases, such as bubbles, that may be contained within fluid reservoir 256 to exhaust chamber 220c (fig. 3A). The needle 272 defines a flow path for fluid 265 to flow from the fluid reservoir 256, through the connector system 270, and into the tube 210.

In one example, the housing 220 includes a retention system 276 that couples the fixed connector system 214 to the fluid reservoir 256. In one example, the retention system 276 includes one or more threads 276a and one or more notches (not shown). The one or more threads 276a threadably engage corresponding threads 278 (fig. 4) defined in the connector system 270 to couple the connector system 270 to the fluid reservoir 256.

Referring to fig. 3, a stop 262 is disposed within the cylinder 260. The stopper 262 is movable within and relative to the barrel 260 to dispense fluid from the fluid reservoir 256. When the cylinder 260 is filled with fluid, the stopper 262 is adjacent the distal cylinder end 264, and the stopper 262 is movable to a position adjacent the proximal cylinder end 266 to empty fluid from the fluid reservoir 256. In one example, the stop 262 is substantially cylindrical and includes a distal stop end 277, a proximal stop end 279, at least one friction element 280, and a counterbore 282 defined from the distal stop end 277 to the proximal stop end 279.

The distal stopper end 277 is open about the periphery of the distal stopper end 277, and is therefore substantially circumferentially open. The proximal stopper end 279 is closed around the circumference of the proximal stopper end 279 and is substantially circumferentially closed. The proximal stopper end 279 comprises a slightly tapered outer surface; however, the proximal stopper end 279 may be flat, convex, or the like. At least one friction element 280 is coupled to the stop 262 about an outer surface of the stop 262. In one example, the at least one friction element 280 includes two friction elements including, but not limited to, O-rings. Friction element 280 is coupled to a circumferential groove defined in an outer surface of stop 262.

The counterbore 282 receives the protrusion 252 of the slider 240 and movement of the slider 240 causes the shoulder 254 of the slider 240 to contact and move the stop 262. In one example, the counterbore 282 includes threads; however, the projection 252 of the slider 240 is not threadedly engaged with the stop 262. Thus, the threads shown herein are exemplary only.

Referring to fig. 3, the fixed connector system 214 mates with and couples to the proximal cylindrical end 266 of the fluid reservoir 256, thereby forming a fluid path from the fluid reservoir 256 to the tube 210. The fixed connector system 214 is coupled to the housing 220 of the fluid infusion device 202 and to the fluid reservoir 256 to seal and secure the fluid reservoir 256 within the housing 220. Actuation of the fluid infusion device 202 then causes the drug fluid to be expelled from the fluid reservoir 256, through the infusion set component 204, and into the patient via the infusion unit 212 at the distal end of the tube 210. Thus, when the stationary connector system 214 is installed as shown in fig. 3, the tubing 210 extends from the fluid infusion device 202 to the infusion unit 212, and the needle 272 provides a fluid path to the patient's body. For the embodiment shown, the fixed connector system 214 is implemented as a removable reservoir cap (or fitment) sized and configured appropriately to accommodate replacement of the fluid reservoir as needed (typically disposable).

Referring to fig. 4, the connector system 270 of the fixed connector system 214 is shown in greater detail. In fig. 4, the connector system 270 is shown without the tube 210 for clarity. The connector system 270 is removably coupled to the housing 220 and retains the fluid reservoir 256 within the housing 220. In this example, the connector system 270 includes a first body portion 300 and a second body portion 302. Each of the first and

second body portions

300, 302 is constructed of a polymer material, such as a polycarbonate material, and each of the first and

second body portions

300, 302 may be formed by any suitable technique, such as injection molding or 3D printing, for example. It should be noted that although the first body portion 300 and the second body portion 302 are shown as separate components, the first body portion 300 and the second body portion 302 may be integrally formed or may be unitary (one-piece), if desired.

The first body portion 300 includes a graspable portion 304 and defines an aperture 306. The graspable portion 304 enables a user to manipulate the connector system 270 to remove or insert the connector system 270 from the housing 220 to remove or insert the fluid reservoir 256. Referring to fig. 5, fig. 5 provides a detailed view of the cross-sectional view of fig. 3 with the fluid reservoir 256, needle 272, and tube 210 removed for clarity. As shown in fig. 5, the aperture 306 extends from the first end 300a of the first body portion 300 to the second end 300b of the first body portion 300. The bore 306 receives the tube 210 and the needle 272, and generally, the tube 210 is coupled adjacent the needle 272 within the bore 306 to define a fluid flow path out of the connector system 270. The second end 300b may also include one or more tabs 308. In this example, the second end 300b defines two tabs 308a having a first width and two tabs 308b having a second width. The first width is different from the second width, and typically, the second width is less than the first width. The tab 308b may be defined adjacent the aperture 306, and the tab 308a may be spaced radially outward from the aperture 306. The

tabs

308a, 308b are each spaced from one another on the second end 300 b. The two

tabs

308a, 308b are received in

respective channels

310a, 310b of the second body portion 302. The

tabs

308a, 308b may be fixedly coupled to the

channels

310a, 310b by ultrasonic welding, adhesives, or the like.

The second body portion 302 is received within the housing 220 to retain the fluid reservoir 256 (fig. 3) within the housing 220. The second body portion 302 has a plane of symmetry 303. Referring again to fig. 4, the second body portion 302 is generally annular and includes a first end 312, a sidewall 314, a second end 316, and an exhaust subsystem 318. The first end 312 defines

passages

310a, 310b and also includes an annular chamber 320. The

passages

310a, 310b and the annular chamber 320 may be defined by a common wall 312a that extends outwardly from a surface of the first end 312. Referring to FIG. 5, the annular chamber 320 extends from the first end 312 to a counterbore 322 at the second end 316. Annular chamber 320 is coaxial with aperture 306 and coaxial with counterbore 322 to receive needle 272 therethrough to define a fluid flow path from fluid reservoir 256 to tube 210 (fig. 3). Generally, the aperture 306, the annular chamber 320, and the counterbore 322 extend along an axis that defines a longitudinal axis 321 of the connector system 270.

In various embodiments, the annular chamber 320 also receives a filter 324. In one example, the needle 272 terminates adjacent the filter 324 such that the needle 272 and the tube 210 are located on opposite sides of the filter 324 to ensure that fluid exiting the fluid reservoir 256 flows through the filter 324 (fig. 3). In one example, the minimum volume of the annular chamber 320 is about 0.7 microliters (mL). Generally, the height of annular chamber 320 is such that needles 272 can be received within annular chamber 320 without piercing filter 324. Annular chamber 320 may be sterilized prior to insertion of filter 324 and, in addition, annular chamber 320 may be plasma treated to increase hydrophilicity, if desired.

The filter 324 comprises a gas trapping filter and is formed of a suitable material, composition, or element such that the drug fluid may readily pass through the filter 324 during fluid delivery operations. The filter 324 may be formed of a hydrophilic, semi-hydrophilic, partially hydrophilic, or primarily hydrophilic material. While a truly hydrophilic material may be desirable, the material used for the filter 324 may be partially or primarily hydrophilic while exhibiting a certain amount of hydrophobicity. In practice, the filter 324 may exhibit up to fifty percent hydrophobicity without adversely affecting the desired performance. For example, the filter 324 may include or be fabricated from a hydrophilic membrane, a hydrophilic sponge material, or a hydrophilic foam material. As will be explained below, the filter 324 also serves to filter particles from the medication fluid during fluid delivery operations. Thus, the pore size of the filter 324 is small enough to inhibit the flow of particulates. In certain embodiments, the pore size is in the range of about 0.45 to 5.00 microns, which is suitable for most medical applications. Non-limiting examples of suitable materials for filter 324 include: a polyacrylate; a polyurethane; nylon; cellulose acetate; polyvinyl alcohol; a polyethylene foam; polyvinyl acetate; a polyester fiber felt; polyester (PET); polysulfones; polyethylene sulfone; collagen; polycaprolactone; and the like. It should be understood that one or more of the materials used to fabricate filter 324 may be treated to enhance the hydrophilic properties, if desired.

One function of the filter 324 is to inhibit the downstream flow of air bubbles. Depending on the particular composition and configuration of filter 324, air bubbles may be blocked by filter 324 and/or retained within filter 324 as the liquid medicant flows downstream. Thus, the filter 324 may be implemented as a gas impermeable membrane or material that also exhibits good hydrophilicity. Thus, no air bubbles are present in the drug fluid downstream of filter 324.

Another benefit of the filter 324 relates to the volumetric accuracy of the fluid delivery system. In certain implementations, the syringe pump is calibrated to deliver a specified volume in response to controlled mechanical actuation (e.g., movement of the syringe plunger in response to controlled rotation of the electric motor). Reducing or eliminating air from the fluid delivery path increases the accuracy of the volume calibration.

In certain embodiments, filter 324 is also used to filter particulates from the drug fluid such that the number of particulates in the downstream drug fluid is reduced. As discussed above, the material used to fabricate the filter 324 may be selected to have a desired pore size to accommodate filtration of particles having a desired size.

In some embodiments, filter 324 also serves to absorb and/or adsorb certain substances, chemicals, or suspended elements from the pharmaceutical fluid. For example, filter 324 may include a material configured or treated to absorb/adsorb lubricant or manufacturing oil associated with the manufacture, assembly, or maintenance of one or more components of fluid reservoir system 230. In this regard, the fluid reservoir for insulin may be manufactured with a trace amount of silicone oil that acts as a lubricant for the plunger of the fluid reservoir 256. Accordingly, filter 324 may include a material, layer, or treatment that reduces, traps, or otherwise removes some or all of the silicone oil from the drug fluid as it passes through filter 324.

In certain embodiments, the filter 324 also serves as a drug reservoir during operation of the fluid delivery system. To this end, the filter 324 may include a drug, medicine, chemical, or composition impregnated therein (or coated thereon, or otherwise carried by the filter 324). As the fluid flows through the filter 324 during fluid delivery operations, an amount of the drug is released into the drug fluid. The medication carried by the filter 324 may be selected to meet the needs of a particular patient, fluid delivery system, medical fluid, etc. According to the exemplary insulin infusion system described herein, the filter 324 is impregnated with a medication that treats the patient site to extend the useful life of the fluid infusion set. For example, filter 324 may be treated with an anticoagulant such as heparin or dextran. As another example, filter 324 may be impregnated or infused with an antiproliferative drug such as rapamycin. It should be understood that these examples are neither exhaustive nor limiting, and that filter 324 may be impregnated, treated or infused with any medication that is appropriate for and suitable for a particular medical condition, fluid delivery system or application. Generally, gas (e.g., bubbles) captured by filter 324 is vented from connector system 270 to exhaust plenum 220c (fig. 3A) through exhaust subsystem 318, as will be discussed further herein.

Referring again to fig. 4, the sidewall 314 extends around the perimeter or circumference of the second body portion 302. The side wall 314 includes a pair of arms 326, threads 278 and a locking socket 328. The arms 326 are substantially opposite one another around the side wall 314. The arm 326 is generally integral with the sidewall 314 and includes a living hinge biasing the arm 326 in a direction away from the sidewall 314. In other words, each arm 326 is defined so as to be biased radially outwardly from the second body portion 302. Engagement of the second body portion 302 with the housing 220 causes compression of the arms 326 until the arms 326 extend and engage corresponding dimples (not shown) defined in the reservoir chamber 220b of the housing 220. Thus, in this example, the arm 326 cooperates with the lock 232 to secure the second body portion 302 to the housing 220. Generally, the arm 326 also provides tactile feedback that the connector system 270 is fully threaded into the housing 220.

Threads 278 are defined around a portion of sidewall 314 so as to be adjacent second end 316. In this example, the threads 278 comprise two threads; however, any number of threads may be employed to couple the connector system 270 to the housing 220. In this example, each thread 278 defines an outlet 330. Outlet 330 is in fluid communication with exhaust subsystem 318 and with exhaust plenum 220c to discharge gases (e.g., bubbles) captured by filter 324 to exhaust plenum 220c (fig. 3A). In one example, referring to fig. 3A, each outlet 330 is in fluid communication with a respective aperture 331 defined by a wall 333 that separates vent chamber 220c from reservoir chamber 220 b. Referring again to fig. 3, the outlet 330 includes an aperture 332 and a seal 334. Apertures 332 are generally defined near the midpoint of the respective threads 278; however, the apertures 332 may be defined by the corresponding threads 278 at any desired location. The aperture 332 is generally circular; however, the apertures 332 may have any desired shape. The seal 334 generally circumscribes the aperture 332, and thus the seal 334 is generally annular. In one example, the seal 334 comprises an O-ring; however, the seal 334 may comprise any suitable sealing means. The seal 334 forms a seal between the second body portion 302 and the wall 333 separating the vent chamber 220c and the reservoir chamber 220b to prevent fluid flow into the vent chamber 220 c.

The locking receptacle 328 receives a portion of the lock 232 to secure or lock the connector system 270 to the housing 220. In one example, the locking receptacle 328 is substantially rectangular; however, the locking receptacle 328 may have any desired shape that cooperates with the lock 232 to secure or lock the connector system 270 to the housing 220.

Referring to fig. 5, the second end 316 defines a counterbore 322. In certain embodiments, a second membrane may be disposed adjacent or coupled to the second end 316 to enable air to vent from the reservoir chamber 220b while preventing fluid from venting out of the reservoir chamber 220 b. In one example, the second membrane comprises a fluoropolymer membrane. Generally, the second membrane has a defined penetration pressure that only allows gas, such as air, to pass through the second membrane, but not liquid.

Exhaust subsystem 318 is in fluid communication with annular chamber 320 to transfer gas captured by filter 324 from annular chamber 320 to exhaust chamber 220c of housing 220. Exhaust subsystem 318 includes a first conduit 340 and a second conduit 342, each of which terminates in a respective outlet 330. In general, a first conduit 340 is defined on a first side of the second body portion 302 and a second conduit 342 is defined on an opposite side of the second body portion 302 such that captured gas is directed from the annular chamber 320 into the exhaust chamber 220c via a respective one of the outlets 330 in at least two different directions. Although exhaust subsystem 318 is described and illustrated herein as including two conduits, namely first conduit 340 and second conduit 342, it should be understood that exhaust subsystem 318 may include any number of conduits.

Each of the first and

second conduits

340, 342 includes a first conduit passageway 344, a second conduit passageway 346, a third conduit passageway 348, and a fourth conduit passageway 350. Each of the first, second, third and

fourth conduit channels

344, 346, 348, 350 are in fluid communication to enable gas, such as trapped air, to be transferred from the annular chamber 320 to the respective outlet 330. The first conduit channel 344 has a first inlet 344a in fluid communication with the annular chamber 320 such that the filter 324 is adjacent the first inlet 344 a. The first conduit channel 344 has a first outlet 344b downstream of the first inlet 344 a. The first conduit channel 344 extends radially outward from the annular chamber 320 and extends along a substantially transverse axis, in one example, substantially perpendicular to the longitudinal axis 321.

In this example, a first valve 352 is coupled between the first outlet 344b and the second inlet 346a of the second conduit channel 346. The first valve 352 comprises a suitable one-way valve including, but not limited to, a poppet valve, a duckbill valve, an umbrella valve, and the like. The first valve 352 allows the trapped gas to flow from the first outlet 344b to the second inlet 346a in only a single direction, thereby preventing or inhibiting backflow into the first conduit channel 344.

The second conduit channel 346 further includes a second outlet 346b downstream of the second inlet 346 a. The second outlet 346b is in fluid communication with a third inlet 348a of a third conduit passageway 348. The second conduit channel 346 extends radially outward from the annular chamber 320 and extends along a substantially transverse axis, in one example, substantially perpendicular to the longitudinal axis 321. In this example, the second conduit channel 346 is spaced from the first conduit channel 344 and is fluidly coupled to the first conduit channel 344 via a first valve 352.

The third conduit passageway 348 includes a third outlet 348b in fluid communication with a fourth inlet 350a of the fourth conduit passageway 350. The third conduit passageway 348 extends substantially along an axis that is substantially parallel to the longitudinal axis 321.

Referring to fig. 6, the fourth conduit channel 350 is shown in more detail. The fourth conduit channel 350 extends along an arc defined by the sidewall 314. The fourth conduit channel 350 includes a fourth outlet 350b in fluid communication with the aperture 332 of the respective outlet 330.

Referring again to fig. 2, the lock 232 securely couples the connector system 270 to the housing 220. In one example, the lock 232 includes a locking member 360 and a biasing member or spring 362. The locking member 360 is substantially D-shaped and includes a base 364 and a curved locking arm 366. The locking member 360 is slidably received within first and

second guides

368, 370 defined by a portion of the housing 220. In this example, respective portions of the curved locking arms 366 are slidably received within respective ones of the first and

second guides

368, 370; however, it should be understood that other configurations are possible.

The base 364 is curved and generally follows the curvature of the housing 220, but it should be understood that the base 364 may be flat or planar. Referring to fig. 5, the base 364 defines an inner surface 364a opposite the outer surface 364 b. The inner surface 364a is coupled to the curved locking arm 366 and defines a first spring seat 374. The first spring seat 374 receives one end of the spring 362. Referring again to fig. 2, the outer surface 364b provides a contact surface for a user to touch to disengage the lock 232 to release the connector system 270 and the fluid reservoir 256 from the housing 220.

The curved locking arms 366 extend around the perimeter or circumference of the second body portion 302 of the connector system 270. In this example, referring to fig. 5, the curved locking arm 366 includes a tab 376 configured to engage the locking receptacle 328 of the second body portion 302 to secure the connector system 270 to the housing 220.

The spring 362 biases the locking member 360 in a first, locked position, as shown in fig. 5. The spring 362 has a first end biased against a first spring seat 374 and a second end biased against a second spring seat 378 defined by a portion of the housing 220. Generally, the spring 362 comprises a coil spring constructed of a metal or metal alloy, but the spring 362 may comprise any suitable biasing member. The base 364 of the locking member 360 may be moved in direction D from the first locked position to the second released position to compress the spring 362 to release the connector system 270 from the housing 220.

Referring to fig. 3, a fluid reservoir system 230 may be coupled to the housing 220 with the housing 220 assembled with the power source 224, the control module 226, and the drive system 228. In one example, a full fluid reservoir 256 is inserted into the housing 220 such that the stop 262 is adjacent to the protrusion 252 of the slide 240. A stationary connector system 214 having a needle 272 and a tube 210 coupled to a connector system 270 is then coupled to the housing 220. In one example, referring to fig. 5, base 364 is moved in direction D to define an opening for receiving connector system 270. The connector system 270 is inserted into the housing 220 and rotated by the first body portion 300, for example, such that the threads 278 engage the threads 276a of the housing 220. The connector system 270 is rotated until the arms 326 engage corresponding dimples defined in the reservoir chamber 220b to couple the connector system 270 to the housing 220. The base 364 of the lock 232 is released and the spring 362 causes the tab 376 to engage the locking receptacle 328, thereby fixedly coupling or securing the stationary connector system 214 to the housing 220.

With the fixed connector system 214 fixedly coupled or secured to the housing 220, the needle 272 pierces the septum 268, thereby defining a fluid flow path for the fluid 265 out of the fluid reservoir 256. With the fixed connector system 214 coupled to the fluid reservoir 256, one or more control signals from the control module 226 may drive the motor 234, thereby rotating the drive screw 238 such that the slide 240 translates linearly. Advancement of the slide 240 into the fluid reservoir 256 moves the stop 262 such that the fluid 265 flows from the fluid reservoir 256 through the fluid flow path defined by the fixed connector system 214.

As fluid flows through needle 272, the fluid passes through filter 324. Any gas (e.g., bubbles) within the fluid is trapped by the filter 324. Since the reservoir chamber 220b typically operates at a pressure that is greater than the pressure in the vent chamber 220c, the trapped gas is drawn through the filter 324 into the first and

second conduits

340, 342. The gas captured by the filter 324 flows from the filter 324 into the first inlet 344a of the first conduit channel 344 of each of the first conduit 340 and the second conduit 342. The pressure of the gas in the first conduit channel 344 causes the first valve 352 to open, thereby discharging gas from the first conduit channel 344 into the second conduit channel 346. Gas flows from the second conduit channel 346 to the third conduit channel 348, and gas flows from the third conduit channel 348 into the fourth conduit channel 350. The gas flows from the fourth conduit channel 350 and exits into the apertures 332 of the respective outlet 330 and then exits into the exhaust plenum 220c (fig. 3A).

To remove fixed connector system 214, e.g., to replace an empty fluid reservoir 256, referring to fig. 5, a force may be applied to base 364 in direction D to bias lock 232 into the second release position. With the lock 232 in the second release position, the first body portion 300 may be rotated to overcome the force of the arm 326 and disengage the second body portion 302 from the threads 276 a. The connector system 270 may then be removed from the housing 220, and the force may be removed from the base 364. As force is removed from base 364, spring 362 returns lock 232 to the first locked position.

Referring to fig. 7, a plan view of an exemplary embodiment of a fluid delivery system 400 is shown that includes a portable fluid infusion device 402 and a fluid conduit assembly in the form of an infusion set component 404. The infusion set component 404 is coupled to the fluid infusion device 402. The fluid infusion device 402 houses a fluid reservoir, such as fluid reservoir 256 (fig. 3), for delivering the drug fluid to a user. Since the fluid infusion device 402 and the infusion set component 404 are substantially similar to the fluid infusion device 202 and the infusion set component 204 discussed with respect to fig. 1-6, only the differences between the fluid infusion device 402 and the fluid infusion device 202 and the infusion set component 404 and the infusion set component 204 are discussed in detail herein.

The infusion set component 404 includes, but is not limited to: a tube 210; an infusion unit 212 coupled to the distal end of the tube 210; and a fixed connector system 414 coupled to the proximal end of the tube 210. The infusion set component 404 defines a fluid flow path that fluidly couples the fluid reservoir to the infusion unit 212. The fluid infusion device 402 is designed to be carried or worn by a patient, and the infusion set component 404 terminates in an infusion unit 212, such that the fluid infusion device 402 can deliver fluid to the body of the patient via tubing 210. Fluid infusion device 402 may utilize a number of conventional features, components, elements, and characteristics of existing fluid infusion devices. For example, fluid infusion device 402 may incorporate some of the features, components, elements, and/or characteristics described in U.S. Pat. nos. 6,485,465 and 7,621,893, the relevant contents of which are incorporated herein by reference.

The fluid infusion device 402 includes a user interface 216 and a display 218 coupled to a housing 420. The user interface 216 includes one or more input devices 222 that can be activated by a user. The housing 420 of the fluid infusion device 202 houses the power source 224 (fig. 3), the controller or control module 226 (fig. 3), the drive system 228 (fig. 3), and the fluid reservoir system 430. Generally, the power source 224, control module 226, and drive system 228 are housed in a pump chamber 220a (fig. 3) defined by the housing 420, and the fluid reservoir system 430 is housed in a reservoir chamber 220b (fig. 8) defined by the housing 420. The housing 420 may have any desired shape to accommodate the various components of the fluid infusion device 402, and thus, it should be understood that the shape and configuration of the housing 420 shown herein is merely exemplary.

Referring to fig. 8, the fluid reservoir system 430 includes a fluid reservoir 256 (fig. 3) and a sealing member 458. Fluid reservoir 256 and sealing member 458 are each received within an opening defined by housing 420. A sealing member 458 is coupled around a perimeter of a portion of the fixed connector system 414 to prevent fluid from entering the reservoir chamber 420b of the housing 420. In one example, the sealing member 458 comprises an O-ring; however, as will be appreciated by those skilled in the art, any suitable means may be used to prevent fluid ingress. In this example, the sealing member 458 includes a triangular end 458a and a notched trailing end 458 b. The triangular end 458a contacts the connector system 470 of the fixed connector system 414. Notch trailing end 458b may contact one or more rings 560 associated with housing 420, as will be discussed in further detail below.

The fixed connector system 414 includes a connector system 470, a needle 272, and a tube 210. As will be discussed, connector system 470 couples needle 272 and tube 210 to fluid reservoir 256 (fig. 3), and includes an exhaust subsystem 518 for exhausting trapped gas, e.g., bubbles, that may be contained within fluid reservoir 256 to the ambient environment surrounding housing 420. The needle 272 defines a flow path for fluid 265 to flow from the fluid reservoir 256, through the connector system 470, and into the tube 210.

In one example, the housing 420 includes a retention system 476 (fig. 3) that couples the fixed connector system 414 to the fluid reservoir 256. In one example, the retention system 476 includes one or more guide rails 476 a. One or more guide rails 476a are defined on opposing walls of the reservoir chamber 220b and generally extend along an axis substantially parallel to the longitudinal axis 421 of the housing 420 and cooperate to receive corresponding grooves 478 defined in the connector system 470 to help retain the connector system 470 within the housing 420. In this example, the reservoir chamber 220b includes two rails 476a and the connector system 470 includes two grooves 478 spaced around the perimeter or circumference of the connector system 470, however, the reservoir chamber 220b and the connector system 470 may each have any number of rails 476a and grooves 478. Generally, each groove 478 is defined about connector system 470 so as to be substantially opposite the other groove 478.

Referring to fig. 7, the fixed connector system 414 mates with and couples to the proximal cylindrical end 266 of the fluid reservoir 256 (fig. 3), thereby forming a fluid path from the fluid reservoir 256 to the tube 210. The fixed connector system 414 is coupled to the housing 420 of the fluid infusion device 202 and to the fluid reservoir 256 (fig. 3) to seal and secure the fluid reservoir 256 within the housing 420. Actuation of the fluid infusion device 402 then causes the drug fluid to be expelled from the fluid reservoir 256, through the infusion set component 204, and into the patient via the infusion unit 212 at the distal end of the tube 210. Thus, when the stationary connector system 414 is installed as shown in fig. 7, the tubing 210 extends from the fluid infusion device 202 to the infusion unit 212, and the needle 272 provides a fluid path to the patient's body. For the embodiment shown, the fixed connector system 414 is implemented as a removable reservoir cap (or fitment) sized and configured appropriately to accommodate replacement of the fluid reservoir as needed (typically disposable).

Referring to fig. 8, the connector system 470 of the fixed connector system 414 is shown in greater detail. In fig. 8, for clarity, connector system 470 is shown without needle 272 and tube 210. The connector system 470 is removably coupled to the housing 420 and retains the fluid reservoir 256 within the housing 420. In this example, the connector system 470 includes a first body portion 500 and a second body portion 502. Each of the first and

second body portions

500, 502 is constructed of a polymer material, such as a polycarbonate material, and each of the first and

second body portions

500, 502 may be formed, for example, by any suitable technique (e.g., injection molding or 3D printing). It should be noted that although the first body portion 500 and the second body portion 502 are shown as separate components, the first body portion 500 and the second body portion 502 may be integrally formed or may be unitary (one-piece), if desired.

The first body portion 500 includes a graspable portion 504 and defines an aperture 506. The graspable portion 504 enables a user to manipulate the connector system 470 to remove or insert the connector system 470 from the housing 420 to remove or insert the fluid reservoir 256. The aperture 506 extends from the first end 500a of the first body portion 500 to the second end 500b of the first body portion 500. The bore 506 receives the tube 210 and the needle 272, and generally, the tube 210 is coupled adjacent the needle 272 within the bore 506 to define a fluid flow path out of the connector system 470. The second end 500b may also include one or more tabs 308. In this example, the second end 500b defines two tabs 308a having a first width and two tabs 308b having a second width. The two

tabs

308a, 308b are received in

respective channels

310a, 310b of the second body portion 502. The

tabs

308a, 308b may be fixedly coupled to the

channels

310a, 310b by ultrasonic welding, adhesives, or the like.

The second body portion 502 is received within the housing 420 to retain the fluid reservoir 256 (fig. 3) within the housing 420. The second body portion 502 has a plane of symmetry 503. Referring to fig. 9, second body portion 502 is generally annular and includes a first end 512, a sidewall 514, a second end 516, and an exhaust subsystem 518 (fig. 8). The first end 512 defines the

passages

310a, 310b, and also includes an annular chamber 520 (fig. 8). The

channels

310a, 310b and the annular chamber 520 may be surrounded by a flange 512a that extends upward from the surface of the first end 512 around the perimeter of the second body portion 502 to provide additional strength to the first body portion 500.

Referring to FIG. 8, an annular chamber 520 extends from the first end 512 to a region adjacent to a counterbore 522 of the second end 516. In one example, the annular chamber 520 is coupled to the counterbore 522 via a passage 520a that is sized to receive the needle 272 (fig. 3). The annular chamber 520 is coaxial with the aperture 506 and with the passage 520a and the counterbore 522 to receive the needle 272 therethrough to define a fluid flow path from the fluid reservoir 256 to the tube 210. Generally, the bore 506, the annular chamber 520, the passage 520a, and the counterbore 522 extend along an axis that is substantially parallel to the longitudinal axis 421.

In various embodiments, the annular chamber 520 also receives a filter 324. In this example, needle 272 terminates adjacent filter 324 such that needle 272 and tube 210 are located on opposite sides of filter 324 to ensure that fluid exiting fluid reservoir 256 flows through filter 324 (fig. 3). In one example, the minimum volume of the annular chamber 520 is about 0.7 microliters (mL). Generally, the height of the annular chamber 520 is such that the needle 272 can be received within the annular chamber 520 without piercing the filter 324. The annular chamber 520 may be sterilized prior to insertion of the filter 324 and, in addition, the annular chamber 520 may be plasma treated to increase hydrophilicity, if desired. Generally, gas (e.g., bubbles) captured by filter 324 is vented from connector system 470 to the ambient environment outside of housing 220 through exhaust subsystem 518, as will be discussed further herein.

Referring again to fig. 9, the sidewall 514 extends around the perimeter or circumference of the second body portion 502 and cooperates with the flange 512a to define an outer surface of the second body portion 502. The sidewall 514 includes a groove 478 and one or more outlets 530. In this example, the outlet 530 includes two outlets 530 separated by a respective one of the grooves 478. A groove 478 is defined from second end 516 by sidewall 514 in a direction toward first end 512.

Each outlet 530 is in fluid communication with exhaust subsystem 518 and with a respective conduit 536 defined through housing 420 (fig. 8) to discharge air captured by filter 324 to the ambient environment surrounding housing 420. Each outlet 530 includes an aperture 532 and a seal 534. The aperture 532 is substantially circular; however, the aperture 532 may have any desired shape. The seal 534 generally circumscribes the aperture 532, and thus the seal 534 is generally annular. In one example, the seal 534 comprises an O-ring; however, the seal 534 may include any suitable sealing device. The seal 534 forms a seal between the second body portion 302 and the reservoir chamber 420b to ensure that trapped gas enters the conduit 536 (fig. 8).

Referring to fig. 8, a membrane 538 substantially surrounds the outlet 530 and the conduit 536. A membrane 538 is positioned between each outlet 530 and each conduit 536 to help remove gases trapped in the reservoir chamber 220 b. In one example, the membrane 538 includes a fluoropolymer membrane. Generally, the membrane 538 has a defined permeation pressure that only allows gases, such as air, to pass through the membrane 538, but not liquids. The second end 516 defines a counterbore 522.

The exhaust subsystem 518 is in fluid communication with the annular chamber 520 to transfer gas captured by the filter 324 from the annular chamber 520 to the conduit 536 of the housing 420. The exhaust subsystem 518 includes a first conduit 540 and a second conduit 542, each of which terminates in a respective outlet 530. Generally, a first conduit 540 is defined on a first side of the second body portion 502 and a second conduit 542 is defined on an opposite side of the second body portion 502 such that captured gas is directed from the annular chamber 520 into the conduit 536 via a respective one of the outlets 530 in at least two different directions. Although the exhaust subsystem 518 is described and illustrated herein as including two conduits, namely a first conduit 540 and a second conduit 542, it should be understood that the exhaust subsystem 518 may include any number of conduits.

Each of the first and second conduits 540, 542 includes a first conduit passageway 344, a second conduit passageway 346, and a third conduit passageway 348. Each of the first conduit channel 344, the second conduit channel 346, and the third conduit channel 348 are in fluid communication to enable gas, such as trapped air, to be transferred from the annular chamber 520 to the respective outlet 530. In this example, a first valve 352 is coupled between the first outlet 344b and the second inlet 346a of the second conduit channel 346. The third conduit passageway 348 includes a third outlet 348b in fluid communication with the aperture 532 of the respective outlet 530.

Conduits 536 are defined on substantially opposite sides of the housing 420 and extend from the reservoir chamber 420b to the outer surface 420a of the housing 420. Conduit 536 includes a conduit inlet 536a that is fluidly coupled to the respective outlet 530 to receive the captured gas from filter 324. The conduit 536 also includes a conduit outlet 536b defined at the outer surface 420a of the housing 420. In one example, the second valve 550 is received substantially entirely through each conduit 536. The second valve 550 comprises a suitable one-way valve including, but not limited to, a poppet valve, a duckbill valve, an umbrella valve, and the like. The second valve 550 allows the trapped gas to flow from the conduit inlet 536a to the conduit outlet 536b and into the surrounding environment in only a single direction, thereby preventing or inhibiting backflow of fluid (including liquid and gas) into the reservoir chamber 420 b.

Referring to fig. 10, the housing 420 further includes one or more rings 560 that cooperate to securely couple the connector system 470 to the reservoir chamber 420b, and thus the housing 420. In fig. 10, tube 210 and infusion unit 212 are removed for clarity, and a portion of housing 420 is shown in phantom. In this example, referring to fig. 10A, the one or more rings 560 include a release ring 562, a flexible ring 564, a retention ring 566, and an anchor ring 568 (fig. 8).

The release ring 562 extends around the circumference of the first body portion 500. Referring to fig. 8, the release ring 562 includes a collar 570 and tabs 572 defined around an outer surface of the release ring 562. The collar 570 provides a gripping surface for a user to manipulate the release ring 562, and the tabs 572 cooperate with the retention ring 566 to couple or decouple the connector system 470 from the housing 420. The release ring 562 also includes a projection 574 defined around the inner surface of the release ring 562. The projection 574 cooperates with the lip 512b of the flange 512a to couple the first body portion 500 to the release ring 562. The release ring 562 may be constructed of any suitable material, and in one example, the release ring 562 is constructed of a polycarbonate polymer material. It should be noted, however, that the release ring 562 may be constructed of any suitable material, such as a polymer, metal, or ceramic material. The release ring 562 may be molded as one piece, or may be printed by, for example, 3D printing.

When the connector system 470 is coupled to the housing 420, the flexible ring 564 surrounds the first body portion 500. The flexible ring 564 is substantially L-shaped in cross-section. The flexible ring 564 can be constructed of any suitable material, and in one example, the flexible ring 564 is constructed of a polymeric material. In one example, the flexible ring 564 is constructed of a polymer rubber-like material, such as a polyurethane thermoplastic. The flexible ring 564 may be molded as one piece, or may be printed by, for example, 3D printing. Referring to FIG. 10, the flexible ring 564 includes a first leg 564a that is substantially perpendicular to a second leg 564 b. The second leg 564b of the flex ring 564 may include a tab 576. Tabs 576 cooperate with recesses 578 of housing 420 to couple or secure flexible ring 564 to housing 420.

The retaining ring 566 retains the release ring 562 when the release ring 562 is coupled to the housing 420. Referring to fig. 8, the retaining ring 566 is substantially annular and includes a tab 580 at a first end that cooperates with the tab 572 to retain the release ring 562. Referring to fig. 10 and 10A, at the second end, the retaining ring 566 includes one or more tabs 582 that are spaced around the circumference or circumference of the retaining ring 566. Tabs 582 engage the end of second leg 564b of flexible ring 564 and generally support flexible ring 564 within housing 420. The retaining ring 566 includes a body portion defined between a first end and a second end that extends along an axis that is substantially parallel to the longitudinal axis 421. The retaining ring 566 may be constructed of any suitable material, and in one example, the retaining ring 566 is constructed of a polymeric material (including, but not limited to, a polyurethane thermoplastic material). It should be noted, however, that the retaining ring 566 may also be constructed of a metal or ceramic material, if desired. The retaining ring 566 may be molded in one piece by a suitable forming operation.

Referring to fig. 8, the anchor ring 568 secures or locks the connector system 470 within the housing 420. Referring to fig. 10A, the anchor ring 568 defines a plurality of elbow-shaped portions that are interconnected in a pattern to define a circumferential ring. The anchoring ring 568 can include a plurality of first legs 568a angled about 90 degrees to about 160 degrees with respect to a respective one of the plurality of second legs 568b, and in one example, the respective first legs 568a are angled about 135 degrees with respect to the respective second legs 568 b. In general, a respective one of the plurality of second legs 568b is coupled to two of the plurality of first legs 568a such that a slot 568c is defined between adjacent portions of the second legs 568 b. Accordingly, the anchor ring 568 further defines a plurality of slots 568 c. Additionally, the anchor ring 568 further defines a plurality of slots 568d formed around a perimeter or circumference of the anchor ring 568 to define a plurality of first legs 568 a.

In general, referring to fig. 8, the length of each of the first and

second legs

568a, 568b is substantially the same and each extends around a perimeter or circumference of the first body portion 500 when the first body portion 500 is coupled to the housing 420. The first leg 568a generally contacts the body of the retaining ring 566 and is positioned below the tab 580. Second leg 568b is adjacent to and in contact with sealing member 458. The anchor ring 568 can be constructed of any suitable material, and in one example, the anchor ring 568 is constructed of a metallic material (including, but not limited to, stainless steel). However, it should be understood that the anchoring ring 568 may be constructed of a polymeric material such as polycarbonate; and may also be constructed of a ceramic material, if desired. The anchor ring 568 may be formed as a unitary body by a suitable forming operation (e.g., 3D printing, stamping, etc.).

Referring to fig. 7, a fluid reservoir system 430 may be coupled to the housing 420 with the housing 420 assembled with the power source 224, the control module 226, and the drive system 228 (fig. 3). Referring to fig. 8, the release ring 562, the flexible ring 564, the retaining ring 566, the anchor ring 568, and the sealing member 458 are all positioned within and coupled to the reservoir chamber 220b of the housing 420. With fluid reservoir 256 coupled to housing 420, a stationary connector system 414 (fig. 7) in which needle 272 and tube 210 are coupled to connector system 470 is coupled to housing 420. In one example, the connector system 470 is inserted into the release ring 562. The contact between the lip 512b and the notch 578 drives the release ring 562 in direction D3. The downward movement of the release ring 562 causes the second legs 568b to engage the tabs 572 of the release ring 562, thereby securely coupling the connector system 470 to the housing 420.

Referring to fig. 7, with the fixed connector system 414 fixedly coupled or secured to the housing 220, a fluid flow path is defined for the fluid 265 to flow from the fluid reservoir 256. With the fixed connector system 414 coupled to the fluid reservoir 256 (fig. 3), one or more control signals from the control module 226 may drive the motor 234, thereby rotating the drive screw 238 such that the slide 240 (fig. 3) is linearly translated. Advancement of the slide 240 into the fluid reservoir 256 moves the stop 262 such that the fluid 265 flows from the fluid reservoir 256 through the fluid flow path defined by the fixed connector system 414.

As fluid flows through needle 272, the fluid passes through filter 324. Any gas (e.g., bubbles) within the fluid is trapped by the filter 324. Since the reservoir chamber 420b typically operates at a pressure that is greater than the pressure outside the housing 420 and in the ambient environment surrounding the housing, the trapped gas is drawn through the filter 324 into the first and

second conduits

340, 342. Gas captured by the filter 324 flows from the filter 324 into the first inlet 344a of the first conduit channel 344 of each of the first conduit 340 and the second conduit 342. The pressure of the gas in the first conduit channel 344 causes the first valve 352 to open, thereby discharging gas from the first conduit channel 344 into the second conduit channel 346. Gas flows from the second conduit channel 346 to the third conduit channel 348 and exits into the apertures 532 of the respective outlets 530. The pressure of the gas at the respective outlets 530 causes the second valves 550 to open, allowing the trapped gas to flow from the exhaust subsystem 518 through the conduits 536, where it is exhausted to the ambient environment outside and surrounding the housing 420.

To remove the connector system 470, for example, to replace an empty fluid reservoir 256, referring to fig. 8, a second force may be applied in direction D3 to urge the anchor ring 568 outward toward the retaining ring 566 and the flexible ring 564, thereby disengaging the anchor ring 568 from the tabs 572 of the release ring 562. With the anchor ring 568 disengaged, the connector system 470 may be removed from the housing 420.

Additionally, the following examples are also provided, which are numbered for ease of reference:

1. a fixed connector system for venting gas from a fluid reservoir of a fluid infusion device. The fixed connector system includes a connector system having a first body portion coupled to a second body portion. The first body portion defines an aperture in communication with the chamber and the counterbore of the second body portion to define a fluid flow path from the fluid reservoir. The chamber of the second body portion is in fluid communication with an exhaust subsystem defined by the second body portion. The exhaust subsystem terminates in an outlet and directs gas in the fluid flow path through the second body portion to the outlet.

2. The fixed connector system of embodiment 1, wherein the chamber is annular and comprises a filter in communication with the fluid flow path that filters the gas from fluid in the fluid flow path to remove the gas from the fluid trapped in the fluid flow path.

3. The fixed connector system of embodiment 1 or 2, wherein the outlet is defined in threads that at least partially surround the second body portion.

4. The stationary connector system according to one of the preceding embodiments, wherein the outlet is in fluid communication with a conduit defined in a housing associated with the fluid infusion device to discharge the gas to an ambient environment outside the housing.

5. The fixed connector system of embodiment 4, wherein the conduit comprises a one-way valve that inhibits fluid flow into the housing.

6. The fixed connector system of the previous embodiment, wherein a housing is provided having a first chamber and a second chamber, wherein the fluid reservoir is removably received within the first chamber and the outlet is in fluid communication with the second chamber to vent the gas to the second chamber.

7. The connector system of one of the preceding embodiments, further comprising a lock at least partially surrounding a portion of the connector system to securely couple the connector system to a housing associated with the fluid infusion device.

8. The fixed connector system of embodiment 7, wherein the lock is slidably coupled to the housing, the lock is movable between a first locked position and a second released position, and the lock is biased to the first locked position.

9. The stationary connector system according to one of the preceding embodiments, further comprising at least one ring disposed within a housing of the fluid infusion device, the ring cooperating with the connector system to securely couple the connector system to the housing.

10. The fixed connector system of embodiment 9, wherein the at least one ring comprises a plurality of rings, one of the plurality of rings coupled to the connector system and movable relative to another of the plurality of rings to securely couple the connector system to the housing.

11. The stationary connector system according to one of the preceding embodiments, wherein the exhaust subsystem comprises a plurality of conduit channels, wherein at least one valve is fluidly coupled between one of the plurality of conduit channels and another of the plurality of conduit channels, and the at least one valve comprises a one-way valve.

12. A fluid infusion device is provided that includes a housing that receives a fluid reservoir and a stationary connector system for venting gas from the fluid reservoir. The stationary connector system includes a connector system having a first body portion coupled to a second body portion, the first body portion defining an aperture, the second body portion including a counterbore that receives a portion of the fluid reservoir, the aperture of the first body portion and the counterbore of the second body portion cooperating to define a fluid flow path from the fluid reservoir, the second body portion including an exhaust subsystem in communication with the fluid flow path, the exhaust subsystem terminating in an outlet, and the exhaust subsystem directing gas in the fluid flow path to the outlet.

13. The fluid infusion device of embodiment 12, wherein the second body portion defines a chamber in fluid communication with the aperture and the counterbore of the first body portion, the chamber in communication with the exhaust subsystem, and the chamber includes a filter in communication with the fluid flow path that filters the gas from fluid in the fluid flow path to remove the gas trapped in the fluid flow path.

14. The fluid infusion device of embodiments 12 or 13, wherein the outlet is defined in threads at least partially surrounding the second body portion, the threads mating with corresponding threads defined on the housing.

15. The fluid infusion device of embodiments 12, 13, or 14, wherein the outlet is in fluid communication with a conduit defined through the housing to discharge the gas to an ambient environment external to the housing.

16. The fluid infusion device of embodiment 15, wherein the conduit comprises a one-way valve that inhibits fluid flow into the housing.

17. The fluid infusion device of one of embodiments 12-16, wherein the housing defines a first chamber and a second chamber, the fluid reservoir is removably received within the first chamber, and the outlet is in fluid communication with the second chamber to discharge the gas to the second chamber.

18. The fluid infusion device of one of embodiments 12-17, further comprising a lock at least partially surrounding a portion of the connector system to securely couple the connector system to the housing.

19. The fluid injection apparatus of one of embodiments 12-18, further comprising at least one ring disposed within the housing that mates with the connector system to securely couple the connector system to the housing.

20. The fluid infusion device of one of embodiments 12-19, wherein the venting subsystem comprises a plurality of conduit channels, wherein at least one valve is fluidly coupled between one of the plurality of conduit channels and another of the plurality of conduit channels, and the at least one valve comprises a one-way valve.

While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, including known equivalents and foreseeable equivalents at the time of filing this patent application.

Claims

1. A fluid infusion device comprising:

a housing having a reservoir chamber that receives a removable fluid reservoir, the fluid reservoir having a first end and a second end;

a connector system having a first body portion coupled to a second body portion, the first body portion defining an aperture in communication with a chamber and a counterbore of the second body portion to define a fluid flow path from the fluid reservoir, the chamber of the second body portion being in fluid communication with an exhaust subsystem defined by the second body portion, the exhaust subsystem terminating in an outlet, and the exhaust subsystem directing gas in the fluid flow path through the second body portion to the outlet; and

at least one ring disposed within the reservoir chamber of the housing, the ring cooperating with the connector system to securely couple the connector system to the housing.

2. The fluid infusion device of claim 1, wherein the chamber of the second body portion is annular and includes a filter in communication with the fluid flow path that filters the gas from fluid in the fluid flow path to remove the gas trapped in the fluid flow path.

3. The fluid infusion device of claim 1, wherein the outlet is in fluid communication with a conduit defined in the housing to discharge the gas to an ambient environment external to the housing.

4. The fluid infusion device of claim 3, wherein the conduit comprises a one-way valve that inhibits fluid flow into the housing.

5. The fluid infusion device of claim 1, wherein the at least one ring comprises a plurality of rings, one of the plurality of rings coupled to the connector system and movable relative to another of the plurality of rings to securely couple the connector system to the housing.

6. The fluid infusion device of claim 1, wherein the at least one ring further comprises a release ring and a retention ring, the release ring comprising a gripping surface and a tab that mates with the retention ring to couple the connector system to the housing.

7. The fluid infusion device of claim 6, wherein the release ring includes a protrusion defined around an inner surface that cooperates with the first body portion to couple the first body portion to the release ring.

8. The fluid infusion device of claim 6, wherein the at least one ring further comprises a flexible ring surrounding the first body portion, the flexible ring including a protrusion that mates with a notch of the housing to couple the flexible ring to the housing.

9. The fluid infusion device of claim 8, wherein the retention ring comprises a plurality of tabs spaced around a perimeter of the retention ring, the tabs cooperating with an end of the flexible ring to support the flexible ring within the housing.

10. The fluid infusion device of claim 9, wherein the at least one ring further comprises an anchor ring defining a plurality of first legs around a perimeter of the anchor ring, the plurality of first legs angled relative to a plurality of second legs, a respective one of the plurality of second legs coupled to a respective two of the plurality of first legs to define a plurality of slots.

11. The fluid infusion device of claim 10, wherein the plurality of second legs cooperate with the tabs to couple the connector system to the housing.

12. The fluid infusion device of claim 1, wherein the venting subsystem comprises a plurality of conduit channels, wherein at least one valve is fluidly coupled between one of the plurality of conduit channels and another of the plurality of conduit channels, and the at least one valve comprises a one-way valve downstream of the chamber of the second body portion.

13. A fluid infusion device comprising:

a connector system having a first body portion coupled to a second body portion, the first body portion defining an aperture in communication with a chamber and a counterbore of the second body portion to define a fluid flow path from the fluid reservoir, the chamber of the second body portion being in fluid communication with an exhaust subsystem defined by the second body portion, the exhaust subsystem terminating in an outlet, and the exhaust subsystem directing gas in the fluid flow path through the second body portion to the outlet;

a release ring comprising a gripping surface and a tab; and

a retention ring that mates with the tabs of the release ring to couple the connector system to the housing.

14. The fluid infusion device of claim 13, wherein the chamber of the second body portion is annular and includes a filter in communication with the fluid flow path that filters the gas from fluid in the fluid flow path to remove the gas trapped in the fluid flow path.

15. The fluid infusion device of claim 13, wherein the outlet is in fluid communication with a conduit defined in the housing to discharge the gas to an ambient environment external to the housing.

16. The fluid infusion device of claim 15, wherein the conduit comprises a one-way valve that inhibits fluid flow into the housing.

17. The fluid infusion device of claim 13, wherein the release ring includes a protrusion defined around an inner surface that cooperates with the first body portion to couple the first body portion to the release ring.

18. The fluid infusion device of claim 13, further comprising a flexible ring surrounding the first body portion, the flexible ring including a protrusion that mates with a notch of the housing to couple the flexible ring to the housing.

19. The fluid infusion device of claim 18, wherein the retention ring includes a plurality of tabs spaced around a perimeter of the retention ring, the tabs cooperating with an end of the flexible ring to support the flexible ring within the housing.

20. The fluid infusion device of claim 19, further comprising an anchor ring defining a plurality of first legs around a perimeter of the anchor ring, the plurality of first legs being angled relative to a plurality of second legs, a respective one of the plurality of second legs being coupled to a respective two of the plurality of first legs to define a plurality of slots, and the plurality of second legs cooperating with the tabs to couple the connector system to the housing.